Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The preliminary amendment filed 09/22/2023 is entered.
Claims 1-18, 24, and 41-43 are currently pending.
The Drawings filed 02/24/2023 are approved by the examiner.
The IDS statement filed 02/24/2023 has been considered. An initialed copy accompanies this action.
37 CFR 1.98(a)(2) requires a legible copy of each cited foreign patent document, each non-patent literature publication or that portion which caused it to be listed, and all other information or that portion which caused it to be listed. Note that, for Foreign Cite No. 1 to 5, Applicant has cited the entirety of each reference but only submitted a copy of the abstract of each foreign patent document. Therefore, unless the references have been cited by the Examiner on Form PTO-892 with a full copy of the reference given, any content of the references beyond the abstract have not been considered.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
Claim 1 recites a hydrogel composition comprising a seaweed extract in a particular concentration and water in a particular concentration. Claim 1 further recites the hydrogel composition is prepared by a method comprising three particular steps a) to c). The limitations describing the three steps how the hydrogel composition is prepared are product-by-process limitations.
Product-by-process limitations are not limited to the recited process steps except to the extent they suggest structure of the product. Here, the product merely requires a hydrogel composition comprising a seaweed extract in a concentration of 3-10 wt.% and water in a concentration of 85-87 wt.%. The product as recited does not necessarily require the three steps describing how the hydrogel composition is prepared because the remainder of the claim sufficiently and fully describes the final structure obtained by the process steps. Accordingly, the three steps in claim 1 describing how the hydrogel composition is prepared involving contacting seaweed extract and water to form a mixture, heating the mixture at a particular temperature range to form a hydrogel, and cooling the hydrogel are extended little patentable weight. The same is true for dependent claim 41 that further limits the heating step’s temperature range and duration. However, claim 24 and its dependent claim 42 are method claims and any recited steps in those claims are assigned full patentable weight.
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974).
Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983).
"[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Claim Objections
Applicant is advised that should claim 4 be found allowable, claim 5 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. A composition where the weight percentages of a seaweed tract and water total 100 wt.% of the composition (per claim 5) appears to be a substantial duplicate of a composition consisting of seaweed extract and water (per claim 4) because a composition consisting of two components contains 100 wt.% of the two components albeit besides any unavoidable impurities. See MPEP § 608.01(m). Appropriate correction/clarification is required.
Claim Rejections - 35 USC § 102 & 103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-18, 24, and 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Ueda et al. (US 6,899,840 B2).
As to claims 1, 2, and 6-8, Ueda et al. teach a gel phase composition comprising made from a sol composition comprising a solvent and a gelling agent (abstract and col. 1 line 63 to col. 2 line 8). The solvent may comprise water in an amount of about 10-99.5 wt.%, preferably 30-90 wt.%, (col. 3 lines 28 and 49-53). A gel phase composition comprising a substantial amount of water, as disclosed, reads on a hydrogel. Polysaccharides are preferred gelling agents (col. 4 lines 56+), and a preferable amount of gelling agent is 0.5-20 wt.%, preferably 1-10 wt.%, (col. 4 lines 40-42). Kappa-carrageenan is a preferred polysaccharide (col. 7 lines 21-45, especially lines 43-45), which is also described as a seaweed extract (Id. in col. 7). See also the other seaweed extracts at col. 7 lines 15-20.
While Ueda et al. fail to sufficiently teach the claimed composition under the meaning of anticipation (i.e., a working example comprising the two components specifically within the claimed concentration ranges), there is nevertheless a strong prima facie case of obviousness of the claimed composition over the cited teachings of Ueda et al. At the time of the effective filing date it would have been obvious to a person of ordinary skill in the art to formulate, provide, or arrive at the claimed hydrogel composition from the cited teachings of the reference with a reasonable expectation of success. Water in an amount overlapping the claimed range is the preferred solvent in the reference composition, and seaweed extracts such as kappa-carrageenan in an amount overlapping the claimed range are preferred gelling agents in the reference composition.
Any remaining limitations in the independent claim are not required because they are product-by-process limitations that do not further limit the structure of the hydrogel composition beyond the content/concentration structure already recited in the claim and addressed above. However, Ueda et al. is indeed sufficient to meet the method steps described in the product-by-process limitations. Ueda et al. further teach the gel is made by providing a sol phase of the composition comprising the solvent and gelling agent (including the mixing the components in a tank), heating the sol phase composition to a temperature at least 5°C higher than the gelling agent’s sol gel transition point (where the gelling agent’s sol gel transition point is as high as 80°C which means the heating temperature can be at least 80°C, overlapping the claimed heating temperature), and cooling the sol phase composition into the gel phase (abstract, col. 1 line 63 to col. 2 line 8, col. 11 line 45 to col. 12 line 27, col. 13 line 54 to col. 14 line 19, and Fig. 1 & 2).
As to claims 3-5, the composition mainly comprises the two above-described solvent and gelling agent compositions. The solvent can preferably only contain water (Id., see col. 5). Any other additional components in the solvent (e.g., a polyhydric alcohol and/or other hydrophilic solvents) are merely optional and need not be present. The gelling agent can preferably only contain a seaweed extract (Id., see col. 6 & 7). Any other additional components in the solvent (e.g., other polysaccharides including non-seaweed-derived polysaccharides, non-polysaccharide gellants such as silicone materials and thermoplastic elastomer, mixtures of gellants, etc.) are merely optional and need not be present. Ueda et al. further teach that in highly preferable embodiments the composition further comprises at least one skin benefit agent (col. 10 line 56+). While this skin benefit agent describes an additive, it is merely optional as its presence is “highly preferable” and not expressly required by the reference. Ultimately, the teachings of Ueda et al. permit the gel composition to only contain water as the solvent and a seaweed extract (e.g., a carrageenan) as the gellant as the only components with no further additives, which meets the claimed "consisting of" language of the claim 5 and the weight percentages of the two components being 100 wt.% of the composition as claim 6. A composition consisting of the two components also clearly consists essentially of the two components, meeting the limitations of claim 3. Arguendo, even if the skin benefit agent/additive were present, the limitations of claim 3 regarding the composition essentially of the two components is still met because the additive’s present clearly does not affect the basic and novel characteristics of the water+seaweed extract gel composition’s gel characteristics.
As to claims 9-12 and 43, while Ueda et al. fail to expressly indicate the gel composition is a phase change material with a particular phase transition temperature point or range, that the composition is biodegradable under certain particular conditions, or has a particular working temperature, these limitations would flow naturally from the cited teachings of the reference because the structure of Ueda et al.’s gel composition (a gel comprising/consisting of up to 99.5 wt.% water and 1-10 wt.% a seaweed extract such as kappa-carrageenan as a gelling agent, Id.) is substantially the same as that of the claims. Also note that both components of the composition (kappa-carrageenan/seaweed extract and water) are naturally occurring and/or bio-derived. "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
As to claims 13 and 18, Ueda et al. teach the gel phase, is compressively rolled to form a shape during production, and may be cut to form a pre-formed object such as a sheet (abstract, col. 1 line 63 to col. 2 line 8, col. 11 line 45 to col. 12 line 27, col. 13 line 54 to col. 14 line 19, at col. 15 line 1 to col. 27 line 46, and Fig. 1 to 5), which meets the limitations of claims 13 (it is capable of being shaped) and 18.
As to claims 14-17, Ueda et al. teach the composition may further comprise additives, as described above. The composition may comprise 1-50 wt.% of a polyhydric alcohol such as glycerin as an additional solvent in addition to water (Id. in col. 5), which reads on the additional presence of glycerol in an amount overlapping that claimed. Alternatively, the composition may comprise 0.01-60 wt.% of a skin benefit agent (Id. in cols. 10 & 11), which reads on the additional presence of an additive in an amount overlapping that claimed. Salts are clearly listed examples of suitable skin benefit agents (Id.). Alternatively, Ueda et al. further teach combining the gelling agent with other substances such as monovalent salts that assist in gelling agent in gelling (col. 9 lines 7-21). Therein, suitable cations for the salts include potassium or sodium and suitable anions include chloride (Id.), meaning Ueda et al. further teach provision of sodium chloride and/or potassium chloride in combination with the gelling agent. While Ueda et al. fail to specify a suitable concentration for the monovalent salt (e.g., sodium chloride and/or potassium chloride), discovery of a sufficient concentration of a monovalent salt to aid in gelling the seaweed extract-based gelling agent merely amounts to routine experimentation motivated by the reference.
As to claims 24 and 41, as described above, Ueda et al. teach the gel is made by providing a sol phase of the composition comprising the solvent and gelling agent including the mixing the components, heating the sol phase composition to a temperature at least 5°C higher than the gelling agent’s sol gel transition point where the gelling agent’s sol gel transition point is as high as 80°C (meaning the heating temperature can be at least 80°C or even at least 90°C, overlapping the claimed heating temperatures), and cooling the sol phase composition into the gel phase (Id. at abstract, col. 1 line 63 to col. 2 line 8, col. 11 line 45 to col. 12 line 27, col. 13 line 54 to col. 14 line 19, and Fig. 1 & 2).
Ueda et al. substantially meets the claimed method steps except the heating temperature overlaps the claimed temperature ranges and lacks a disclosure of the duration the heating should occur for. However, at the time of the effective filing date it would have been obvious to a person of ordinary skill in the art to arrive within the claimed limitations from the cited teachings of the reference with a reasonable expectation of success. The disclosed heating temperature overlaps the claimed heating temperature ranges, and it would have been obvious to a person of ordinary skill in the art to discover an optimum, or even merely a workable or sufficient, duration the heating should occur in order to sufficiently form the reference’s gel. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 1-13, 18, 24, and 41-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Iijima et al. ("Effect of thermal history on kappa-carrageenan hydrogelation by differential scanning calorimetry", Thermochimica Acta, 452, 2007, 53-58).
Iijima et al. teach a hydrogel comprising κ-carrageenan and water (abstract and §2.2 on p.174). κ-carrageenan is a seaweed extract. The hydrogel is made by dissolving 0.5-5 wt.% of κ-carrageenan in deionized water, heating at 105°C for 2h, and then maintained at below 25°C (i.e., allowed to cool) for 10-30 min (Id., see §2.1). If this were not enough, see also §2.2 on p.54 where the hydrogel is subsequently tested for certain properties in a process that explicitly heats the hydrogel sample from 25°C to 90°C, which clarifies the hydrogel is indeed intrinsically/inherently allowed to cool during production (it could not be heated from 25°C to 90°C if it were not previously cooled). While the presence of any particular method steps are not required to meet the product-by-process limitations of claims 1 and 41, the cited process certainly meets the limitations recited in method claims 24 and 42. 105°C as disclosed is approximately 100°C as claimed (the claimed modifier “approximately” permits other heating temperatures slightly beyond the end point values so long as they about, around, or approximate to the recited end points), and 2h as disclosed is certainly within approximately 1 hour to approximately 3 hours as claimed. Exemplary hydrogels appear to only contain 3.0 wt.%, 4.0 wt.%, or 5.0 wt.% κ-carrageenan and the remainder water (see, e.g., Fig. 1), which falls within the claimed concentration ranges of claims 1 and 2 (i.e., 3.0 wt.% seaweed extract and 97.0 wt.% water, 4.0 wt.% seaweed extract and 96.0 wt.% water, or 5.0 wt.% seaweed extract and 97.0 wt.% water, respectively) as well as directly meets the claimed "consisting of" language of the claim 5 and the weight percentages of the two components being 100 wt.% of the composition as claim 6. A composition consisting of the two components also clearly consists essentially of the two components, meeting the limitations of claim 3. Iijima et al. also teach a product formed from the hydrogel (see §2.1 & 2.2 on p.54 where the hydrogel is formed in a DCS pan and a pan having a volume of 70 µL), which meets the limitations of claim 18. This also read reads on the limitation of claim 13 that the composition is mouldable (it is capable of being shaped).
While Iijima et al. fail to expressly indicate the composition is a phase change material with a particular phase transition temperature point or range, that the composition is biodegradable under certain particular conditions, or has a particular working temperature, these limitations are presumed inherent in the cited hydrogel in the reference. The same is true for the mouldable limitation of claim 13 (capability of the composition to be shaped/molded) in the event the above forming in a pan does not sufficiently meet this limitation. The structure disclosed in the reference (a hydrogel consisting of 3.0 wt.% seaweed extract and 97.0 wt.% water, 4.0 wt.% seaweed extract and 96.0 wt.% water, or 5.0 wt.% seaweed extract and 97.0 wt.% water, Id.) is identical to that of the claims such that the additionally claimed features are presumed inherent from the reference. Also note that both components of the composition (κ-carrageenan and water) are naturally occurring and/or bio-derived.
"Products of identical chemical composition can not have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1254 1255, 195 USPQ 430, 433 (CCPA 1977). "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best (Id.). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).
Claims 1-13, 18, 24, 41, and 43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kozbial et al. ("Study on the friction of κ-carrageenan hydrogels in air and aqueous environments", Materials Science and Engineering, C38, 2014, 173-179).
Kozbial et al. teach a hydrogel comprising κ-carrageenan and water (abstract and §2.1 bridging p.53 & 54). κ-carrageenan is a seaweed extract. The hydrogel is made by adding 2 or 3 wt.% of K-carrageenan to distilled water and heating to 85°C (Id., see §2.2). The hydrogel is intrinsically/inherently allowed to cool as it is subsequently tested at room temperature-commensurate temperature conditions after formation (see the nanotriborometer testing conditions of and within 22-25°C in Table 1). While the presence of any particular method steps are not required to meet the product-by-process limitations of claims 1 or 41, the cited process certainly meets the limitations recited in method claim 24. However, the disclosed method steps in the reference are so specific they actually anticipate the claimed product-by-process limitations in claim 1. An exemplary hydrogel appears to only contain 3 wt.% of the κ-carrageenan and the remainder water (Id.), which falls within the claimed concentration ranges of claims 1 and 2 (i.e., 3 wt.% seaweed extract and 97 wt.% water) as well as directly meets the claimed "consisting of" language of the claim 5 and the weight percentages of the two components being 100 wt.% of the composition as claim 6. A composition consisting of the two components also clearly consists essentially of the two components, meeting the limitations of claim 3. Kozbial et al. also teach a product formed from the hydrogel (see §2.3.1 on p.174 where a 33 mm x 3.8 mm sample is tested for certain properties), which meets the limitations of claim 18. This also read reads on the limitation of claim 13 that the composition is mouldable (it is capable of being shaped). Alternatively, Kozbial et al. tests the compressive elasticity of the hydrogel that revealed it is elastic and deformable (see at least Table 2, the right column of page 174, and the left column of page 175), which also reads on the limitation claim 13 that the composition is mouldable (it is capable of being shaped).
While Kozbial et al. fail to expressly indicate the composition is a phase change material with a particular phase transition temperature point or range, that the composition is biodegradable under certain particular conditions, or has a particular working temperature, these limitations are presumed inherent in the cited hydrogel in the reference. The structure disclosed in the reference (a hydrogel consisting of 3 wt.% κ-carrageenan and 97 wt.% water, Id.) is identical to that of the claims such that the additionally claimed features are presumed inherent from the reference. Also note that both components of the composition (κ-carrageenan and water) are naturally occurring and/or bio-derived.
"Products of identical chemical composition can not have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1254 1255, 195 USPQ 430, 433 (CCPA 1977). "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best (Id.). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).
The remaining references listed on Forms 892, 1449, and PCT 210 have been reviewed by the examiner and are considered to be cumulative to or less material than the prior art references relied upon or described above.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R DIAZ whose telephone number is 571-270-0324. The examiner can normally be reached Monday-Friday 9:00a-5:00p EST.
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/MATTHEW R DIAZ/Primary Examiner, Art Unit 1761
/M.R.D./
September 23, 2025